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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE Sterile Needle Counter

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  Class 2 Device Recall MEDLINE Sterile Needle Counter see related information
Date Initiated by Firm April 24, 2018
Create Date May 25, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-1932-2018
Recall Event ID 80017
Product Classification Needle, suturing, disposable - Product Code GAB
Product MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A

Product Usage:
A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
Code Information Lot Numbers: 67016114501 67016114502 67016114503 67016124501 67016124503 67016124504 67017024501 67017024502 67017024503 67017024504 67017034503 67017064503 67017084503 67017094501 67017094502 67017104501 67017104502 
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
FDA Determined
Cause 2		 Package design/selection
Action Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704.
Quantity in Commerce 38464 units
Distribution Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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